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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC/COVIDIEN FORMERLY MICRO THERAPEUTICS, INC. DBA EV PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER

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MEDTRONIC/COVIDIEN FORMERLY MICRO THERAPEUTICS, INC. DBA EV PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED 350 18
Device Problem Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/29/2016
Event Type  malfunction  
Event Description
The stent became detached in the delivery catheter.
 
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Brand NamePIPELINE EMBOLIZATION DEVICE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MEDTRONIC/COVIDIEN FORMERLY MICRO THERAPEUTICS, INC. DBA EV
9775 toledo way
irvine CA 92618
MDR Report Key6099823
MDR Text Key59789349
Report Number6099823
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Patient
Type of Report Initial
Report Date 10/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/01/2019
Device Model NumberPED 350 18
Device Lot NumberA249773
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/19/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/12/2016
Event Location Hospital
Date Report to Manufacturer10/12/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 11/14/2016 Patient Sequence Number: 1
Treatment
UNKNOWN.
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